BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 2241479 · Received August 19, 2011

    Report

    Report Number
    8030665-2011-00058
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    November 14, 2010
    Report Date
    August 19, 2011
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW: THE DEVICE HISTORY OF THIS PRODUCT AND LOT WAS REVIEWED AND THE FOLLOWING WAS FOUND: THE ASSEMBLY OF THIS PRODUCT DID NOT HAVE ANY NCRS OR DEVIATIONS DOCUMENTED DURING THE MANUFACTURING PROCESS RELATED TO THIS FAILURE MODE. ALL APPLICABLE TESTS DURING THE IN-PROCESS AND FINAL INSPECTIONS WERE CONDUCTED IN ORDER TO ENSURE PRODUCT INTEGRITY AND WERE DOCUMENTED WITH ACCEPTABLE RESULTS ACCORDING TO APPLICABLE PROCEDURES. CASSETTES LOT NUMBER USED IS E271025 USED TO PRODUCE CODE 050-87212, LOT NUMBER 10HR08086 WAS REVIEWED AND NO ISSUES WERE REPORTED DURING MANUFACTURING PROCESS. IN PROCESS INVESTIGATION: THE LIBERTY CYCLER PROCESS WAS INVESTIGATED TO DETECT ANY POTENTIAL SOURCE OF DAMAGE AT THE FILM AND THE FOLLOWING TO BE CONSIDERED: AFTER THE LASER MACHINE SEALS THE FILM TO THE CASSETTE MOLDED PART A 100% LEAK TEST IS PERFORMED TO THE CASSETTE ASSEMBLIES. THERE IS A 100% LEAK TEST AFTER THE SET IS COMPLETELY ASSEMBLED. NO SHARP OBJECTS ARE USED IN THE MANUFACTURING AREA. POTENTIAL CAUSES OF DAMAGED FILM: SHARP EDGES ON MUSHROOM HEADS, BURR ON MUSHROOM HEADS. SAMPLE ANALYSIS: AN ACTUAL SAMPLE WAS RECEIVED. CODE 050-87212 LOT 10HR08086. A VISUAL EXAMINATION WAS PERFORMED AFTER THE LEAK TEST AND A HOLE WAS FOUND ON THE FILM OF THE CASSETTE. PERFORMED A LEAK TEST BY INTRODUCING WATER INTO THE CASSETTE AND THE LEAK WAS CONFIRMED, THE HOLE ON THE FILM CAUSING THE LEAK. VISUAL EXAM/INSPECTION WITH THE MICROSCOPE WAS PERFORMED TO THE CASSETTE HARD PLASTIC AFTER LEAK TEST AND NO FLASHES ON THE CASSETTE WERE FOUND. CONCLUSION: THE REPORTED COMPLAINT IS CONFIRMED. THERE IS NO CAUSE IDENTIFIED DURING THE MANUFACTURING OF THIS PRODUCT SINCE PRODUCT IS 100% LEAK INSPECTED FOR LEAKS PRIOR TO PACKAGING. PERFORMED A VISUAL ANALYSIS WITH MICROSCOPE AND NO MALFORMATIONS SUCH AS FLASHES WERE FOUND THAT COULD CAUSE FILM DAMAGE WERE FOUND. A CAPA (B)(4) WAS OPENED FOR CASSETTE LEAKS AND CORRECTIVE/PREVENTATIVE ACTIONS WERE COMPLETED 04/2010. CAPA HAS BEEN RE-OPENED IN ORDER TO INVESTIGATE FURTHER AND WORK ON NEW CORRECTIVE/PREVENTATIVE ACTIONS TO MITIGATE COMPLAINTS.

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED REGARDING A PERITONEAL DIALYSIS PATIENT. IT WAS REPORTED THAT WHILE PATIENT WAS CONNECTED AND HE PROCEEDED TO DRAIN, IT WOULD NOT DRAIN. THEY THEN TRIED TO FILL AND IT WOULD NOT FILL. THEY OPENED THE DOOR TO REMOVE THE CASSETTE AND A LEAK WAS NOTED. THE SAMPLE WAS SAVED. THERE IS NO REPORT OF ANY ILL EFFECT OR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, DUAL PATIENT CONNECT PERITONEAL DIALYSIS TUBING TREATMENT SET FKX REYNOSA MANUFACTURING NA 10HR08086

    Patients

    Seq Age Sex Outcome Treatment
    1 NA LIBERTY DIALYSIS MACHINE